A Multicenter, Randomized, Open-Label, Controlled Study Comparing the Efficacy, Safety and Cost-Effectiveness of a Sequential Therapy with RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-Forming Solution with Amorolfine Nail Lacquer Alone in Dermatophytic Onychomycosis

Abstract

Background: The efficacy of topical antifungals is controversial. Objective: To compare the efficacy and safety of a sequential (SEQ) treatment with chemical nail avulsion and topical antifungals to amorolfine nail lacquer in dermatophytic onychomycosis. Methods: This was a randomized, parallel-group, controlled study comparing a 36-week SEQ treatment with chemical nail avulsion with RV4104A ointment (class I medical device containing 40% urea) followed by ciclopirox cream for 8 weeks and ciclopirox nail lacquer for 25 weeks (SEQ group) to amorolfine nail lacquer for 36 weeks (AMO group). Patients had to have a big toenail onychomycosis, sparing the matrix. The primary efficacy criterion was complete cure at week 48. A cost-effectiveness analysis was performed. Results: A total of 142 patients were randomized. The complete cure rate at week 48 was significantly higher in the SEQ group than in the AMO group (36.6 vs. 12.7%, p = 0.001). Clinical cure at week 48 was observed in 53.5% of patients in the SEQ group versus 17% in the AMO group (p < 0.01). The cost of cure per patient was 50% lower with SEQ treatment (EUR 33) compared with amorolfine (EUR 76). Conclusion: A treatment of onychomycosis comprising chemical avulsion of the pathological nail, ciclopirox cream and nail lacquer is significantly more effective than amorolfine nail lacquer.

Ciclopirox 8% HPCH Nail Lacquer in the Treatment of Mild-to-Moderate Onychomycosis: A Randomized, Double-Blind Amorolfine Controlled Study Using a Blinded Evaluator

“…However, in the present trial, the efficacy of amorolfine 5% nail lacquer (with a complete cure rate of about 12%) is higher than the results given in the study of Elewski et al [14] (where the complete cure rate was 0.96%) and substantially in line with the data obtained in the study of Paul et al [13] (12.7%).…”

“…In a recent multicenter, randomized, open-label and controlled study conducted on 142 onychomycotic patients, amorolfine 5% showed complete cure in 12.7% [13] .…”

To what extent do in vitro tests correctly predict the in vivo residence of nail lacquers on the nail plate?

“…4e5, it can be seen that much of the lacquer film (and hence drug) is lost from the nail plate within 3e4 days of application. This could be partly responsible for the relatively low success rate of Curanail in the treatment of onychomycosis; a recent study reported a complete cure rate of only 13% in 71 patients with toenail onychomycosis who applied amorolfine lacquer twice weekly for a period of 36 weeks [24]. Daily (rather than weekly) application or reformulation of this lacquer to improve its residence on the nail, such that a drugloaded film is present on the nail plate surface, especially on the fungally-infected parts, at all times, is therefore likely to improve its success rate in the topical treatment of onychomycosis.…”

UV-curable gel formulations: Potential drug carriers for the topical treatment of nail diseases

“…Oral therapy carries the inherent disadvantages of systemic adverse effects, drug interactions and contraindications, and is subject to a failure rate of 20%, as well as a relapse rate of 25% (Gupta, 2012;Roberts, 1999). Topical therapy, on the other hand, has a low success rate with currently available medicines, for example, 13-54% complete cure rates from amorolfine nail lacquer (Lauharanta, 1992;Paul et al, 2013;Reinel and Clarke, 1992), similarly low cure rates from ciclopirox nail lacquer (Gupta and Joseph, 2000), under 20% complete cure rate of efinaconazole solution (Tosti, 2013) and under 30% cure rate of tavaborole solution (Markham, 2014). Nail psoriasis affects approximately 1% of the population (Reich, 2009) and its treatment may involve repeated injections of corticosteroids into the nail folds, injections of biological agents such as adalimumab, photochemotherapy, topical or systemic treatment depending on the symptoms (Oram and Akkaya, 2013).…”